3.2.2 imported health food 

 

For record after record management information system login name, enter the system through http://bjba.zybh.gov.cn website, read them carefully and in accordance with the relevant requirements, item by item, fill in the record and apply for registration product related information, item by item printing system automatically generated with bar codes, check code in the registration application form, product formula, labels, instructions, product technical requirements, etc., together with the other record filing materials (specific see 6 imported health food record filing materials and project requirements), page by page in the text seal of archival filing people (issued by the inspection agency inspection report, except the notarial documents, documents). If a person has no stamp, he may sign or sign a signature chapter instead. 

 

For the record to clear all the record paper materials scanning into color electronic (PDF) uploaded to health food registration management information system, submitted after confirmation, and shall be submitted to the state food and drug supervision and administration bureau administrative processing services to submit 1 full set of original record filing materials. 

 

Issue a record number, archive and public 

 

If the filing material meets the requirements, the administrative department for the record shall record the record, issue the record number and make the record certificate according to the relevant format; If the applicant fails to meet the requirements, he shall inform the record-keeping person of the relevant materials at once. 

 

The food and drug supervision and administration department shall, in accordance with the "health food registration and filing management method" the requirements of the catalog of health food raw material in health food registration, supervision and administration work. The record holder shall keep a complete archival filing for the record. 

 

Number issued to the original registered product in the filing management department for the record, he shall notify technical evaluation institutions of the cancellation of the original registration certificate and the approval number, or termination of the original application for registration. 

 

The requirement of the filing materials form 

 

4.1 health food record filing materials shall comply with the health food registration and filing management measures for the catalog of health food raw materials and auxiliary materials, inspection and evaluation regulations and normative documents, the provisions of the mandatory standard. 

 

The provision of a health food record shall be filled in strictly according to the requirements of the management information system for the record. 

 

The application materials project catalogue and page number are applied to the homepage of 4.3. Each item should be separated by a separate page, with the name of the material and the number and page number of the material in the catalogue. 

 

The corresponding content of the material (such as product name, record person name, address, etc.) should be consistent. The disagreement shall be submitted in written description, reasons and basis. 

 

The document is printed in A4 format, and the Chinese language is not less than the number 4 in the song body, and the English language is not less than 12 words, the content should be complete and clear. 

 

The project and requirements of domestic healthcare food filing materials 

 

5.1 health food registration form, and the legal responsibility commitment of the record person responsible for the authenticity of the submission materials 

 

The record people by health food registration management information system for the record after information, product information, for the record registration form and legal liability undertaking will be generated automatically. The record holder shall submit the post according to the 3.2 requirements for printing and sealing. 

 

Article 5.2 the registration certificate of the person subject to the record 

 

Shall provide the business license, unified social credit code/organization code legal entity the documents conform to the laws and regulations such as the scanning, and carrying the health care food other production license certificate scanning. 

 

The original registrant shall also provide the document scan of the health food registration certificate. The original registrant is exempted from the provision of the document of production license of the health food. 

 

5.3 product ingredients 

 

The 5.3.1 product formula is automatically generated according to the registered person, including the name and quantity of raw materials and supplementary materials. 

 

The raw materials should be in accordance with the provisions of the health food raw materials catalog, which shall be in accordance with the requirements for the applicable supplementary materials for the medical food record products. 

 

The quantity of raw materials and auxiliary materials is used for the production of 1000 minimum dosage units. 

 

5.3.2 used by the pretreatment of raw materials, pretreatment of raw materials materials shall conform to the provisions on the catalog of health food raw materials, auxiliary materials used should comply with the health food for the record available accessories related product requirements. 

 

The record information provided, it shall respectively lists the pretreatment of raw materials used by the raw materials, auxiliary materials name and dosage, and clearly indicate the pretreatment of the raw material information. If the pretreatment of raw materials used raw materials and auxiliary materials and other raw materials are the same, put on record in the products listed are the raw materials is not repeated, the usage shall be the cumulative dosage, and shall not exceed the scope of available materials and allow maximum usage. 

 

5.3.3 the original registrant when applying for the recordation of the products, if the raw materials do not conform to the catalog of health food raw materials or other related technical requirements, the record people should adjust the product formula and related technical requirements to meet the requirements, and instructions, but don't add material species. 

 

5.4 production process materials 

 

The production process flow diagram and description shall be provided. Process flow diagram in the form of a graph symbols to identify raw materials and auxiliary materials through the process of production and processing to get the final product, should include the main process, key process control points, etc. The process flowchart and process description shall be consistent with the production process description in the requirements of product technology. 

 

The use of pre-treated raw materials should be marked in the process flow diagram and the presentation. 

 

5.4.2 shall not alter the chemical structure and composition of the raw materials in the raw materials catalog of the health food raw materials by means of extraction and synthesis. 

 

The choice of dosage form should be reasonable. The dosage form should be determined according to the optimum population of the product, avoiding the risk of food safety due to the improper choice of dosage form. 

 

5.5 safety and health function evaluation materials 

 

5.5.1 shall provide inspection reports on the functions of the three batches of the products, such as the functional components or the signature component, the hygiene and the stability of the products. 

 

The record person should make sure that the source of the sample is clear and traceable. The domestic record product shall be the sample produced by the medium and above production scale. 

 

The registered person has the ability to self-check the product; If the record person does not have the ability to test, it shall entrust an inspection institution with legal qualifications for examination. 

 

To provide the instructions for the reasonable use of raw materials and supplementary materials, as well as specifications of product labelling and product technical requirements to formulate relevant regulations. 

 

If the original registrant adjusts the product formulation or product technical requirements for the record, the relevant information shall be provided according to 5.5.1. If the product formulation and technical requirements of the product are not adjusted, the inspection report submitted in the original declaration may be provided. 

 

The type, name and standard of the packaging materials that are directly exposed to the product 

 

The type, name, standard number of packaging materials that are directly exposed to the product shall be provided. 

 

Product label, specification sheet 

 

The product label should comply with relevant laws, regulations and other relevant regulations, and the contents of the description shall be consistent with the relevant content of the instruction. 

 

The product manual shall be automatically generated according to the record person, and shall comply with the following requirements: 

 

The product name should comply with relevant laws and regulations such as the regulation of health food registration and filing. 

 

(1) the name of the product is made up of the name of the trademark, general name and attribute name. After the record person enters the name of the trademark, the name of the raw material and the product dosage form, it can choose independently in the name of the product automatically generated by the filing system. 

 

(2) if the registered trademark is used, it shall provide the trademark registration certificate or the use of authorization letter for the registered trademark. 

 

(3) the same enterprise shall not use the same formula for the registration of health food with different names. You may not use the same name for different formulations of health food. 

 

The same formula refers to the situation of the product's raw material, the variety of the auxiliary materials and the amount of the dosage. 

 

The same name refers to a situation where the product's trademark name, generic name, attribute name (including certain people, tastes, etc.) are identical. 

 

The ingredients are listed in the 5.3 product recipe. 

 

All the ingredients are listed in the 5.3 product formulation. 

 

【 efficacy ingredients or signature ingredients and content 】 should include the effect composition or the signature ingredient name and content. The name of the function or the signature ingredient should be the same as the corresponding indicator in the product technical requirement. 

 

The nutrient supplements product efficacy components or iconic component content (marked) consistent with the minimum technical requirements of products as well as, and meet the requirements of the catalog of health food raw materials suitable for daily intake. 

 

Nutrient supplements product name should be marked efficacy composition and content (marked), its efficacy component name for all raw materials corresponding nutrients, the order and the catalog of health food raw materials of nutrients in the order the same; Efficacy composition label value is according to the formula, production technology, and other products comprehensive technical requirements determine the minimum consumption of certain nutrients content in the unit to determine the value, the marking value should meet the requirements of the product technology efficacy component index scope of the provisions and the catalog of health food raw materials suitable for daily intake. The method is "each containing", "each containing" "contains", etc. 

 

[appropriate crowd] comply with the regulations of the catalog of health food raw materials, and for the record provided requirements of management information system, and safe to eat, there is a clear health functional requirements and the products suitable for the archival filing of certain people. 

 

Appropriate crowd of nutrient supplements should comply with the crowd in the catalog of health food raw material classification, labeled "to add XX, XX (nutrients) + + age group" or "to add XX, XX (nutrients) adults, pregnant women, lactating women", and shall meet the following requirements: 

 

(1) when selecting appropriate crowd when two or more successive ages, ages merger shall be marked, such as appropriate crowd at the same time, suitable for 7-10 years old (including 7 and 10 years old crowd, hereinafter the same), at the age of 11-13, is marked for 7-13. 

 

(2) products containing three or more vitamins may be labeled as "XX people who need multivitamins"; Products containing three or more minerals can be labeled "XX people who need to replenish various minerals"; When there are more than three types of vitamins and minerals (including three types), it can be labeled as "XX people who need a multivitamin." 

 

(3) contains three or more B vitamins (vitamin B1, vitamin B2, vitamin B6, vitamin B12, folic acid, niacin, pantothenic acid, etc.) products can be labeled "XX people" to add a variety of B vitamins. 

 

People should be classified according to the catalogue of raw materials for healthy food. Should include: suitable for the crowd except for certain people, the existing scientific evidence is insufficient to support the product is suitable for 3 people under age, pregnant women, lactating women, such as specific people, as well as the present provisions shall be marked clearly specific people. You should also meet the following requirements: 

 

(1) product dosage forms are selected for tablets, capsules, etc. 

 

(2) according to the applicable scope of the raw materials and auxiliary materials used by the product, it is not suitable for the population. If the range of compounds used is "over 4 years old", the inappropriate population should include "people under 3 years old". 

 

(3) the inappropriate population of the nutrient supplement should include people under 1 (including 1 year old); The age group should be labeled when the unsuitable group chooses two or more consecutive age groups. 

 

Health function should be labeled as a health food raw material catalog. 

 

The nutrient supplement should list all the vitamins and minerals that are to be replenished. The statement is "XX, XX". 

 

Products containing three or more vitamins can be labeled as "supplemental multivitamins." Products containing three or more minerals can be labeled as "supplemental minerals"; Contains vitamins and minerals are the kinds of more than three (including three), can be labeled "multivitamin minerals," but not "add one or more of the following raw material name + vitamins minerals" form of expression. 

 

Products containing three or more B vitamins can be expressed as "supplemental B vitamins." 

 

The consumption and consumption method should be consistent with the scientific basis, safety and health function evaluation materials. The expression of consumption and consumption methods should be standardized and detailed in order to be described in the order of consumption (the number of daily servings and consumption). If different kinds of suitable people need to be consumed according to different consumption, the consumption should be labeled according to the appropriate population. 

 

In the product of nutrient supplement, the total daily consumption of solid form products should not exceed 20 grams, and the total amount of liquid form products should not exceed 30 milliliters per day. 

 

Specification: the weight or volume of the minimum unit (the minimum unit) (not including the packing material). For example: the capsule refers to the weight of the content. Sugar coat refers to the weight of the core before the icing. The film garment should check the weight after the coating. The product specification should also match the product consumption method and consumption. The tablet is Xg/tablet, and the capsule is Xg/particle. Oral liquid is Xml/bottle (or branch); The particle is Xg/bag. 

 

A applications can only be put on record a product specifications, such as the need to record multiple specifications, should according to record change procedure application, conform to the requirements of the change, in the comments section of the registration certificate of the specifications of the list will increase. The same product shall not be able to obtain multiple filing vouchers in different specifications. 

 

The original registrant products for the record, if the original approval certificate or has applied for registration of products have multiple specifications and consumption, edible method, for the record, shall fill in a specifications, the specifications and other consumption, edible method remark items in the registration certificate to the following. 

 

The storage method should be determined according to the product characteristics and stability test. If the storage method is refrigerated and other special conditions, the storage conditions shall be listed. 

 

In the case of "XX days", the term "XX days" shall be stated in "XX days". The product of the accelerated stability test shall not exceed 24 months. 

 

"This product should not be used as a substitute for medicine. People who are appropriate to the population do not recommend this product." Nutrient supplement products should also be added "should not exceed the recommended amount or be eaten with the same kind of nutrient". The relevant content should also be added according to research and development, scientific consensus and product characteristics. In the case of aspartame in the supplementary materials, the patient should be marked with the use of acetone urine; Do not chew, contain, or swallow. 

 

The technical requirements for the product of 5.8 products 

 

Record shall ensure product technology content is complete, consistent with test report test results, and in accordance with the current laws and regulations, technical specifications, the national food safety standards, the provisions of the catalog of health food raw materials. 

 

The registered person automatically generates the technical requirements of the product after filing the information in the health food registration management information system. 

 

The registered person is automatically generated after filing the information in the health food file management information system. 

 

List all raw materials and dosage according to the 5.3 product recipe 

 

All the ingredients and quantities are listed in accordance with the 5.3 product formulation. 

 

The main process and key process parameters should be chosen according to the actual process operation procedure. The main processes described in the same description can be selected based on the actual production operating procedures. 

 

The type, name and standard of direct contact product packaging materials shall be in accordance with the material requirements of 5.6 items. 

 

[sensory requirements] should describe the color, taste, smell, status of the product's appearance (color, state, etc.) and content. Do not describe the appearance of the packaging material and the color of the capsule. 

 

【 identify 】 the product identification method can be determined according to the product formulation and the relevant research results. If the identification is not formulated, the reasons for the failure shall be provided. 

 

[physical and chemical indexes] should indicate the name of physicochemical index, index value and test method. If the test method is a national standard, local standard or normative document, the text number of a standard or normative document shall be listed; Detection methods for put on record in the national standards and local standards or revised on the basis of normative documents, include standard number or normative documents of title, document number, detail the revised content at the same time; The test method is formulated for the record person study, should list the test method full text, and provide this method to the product suitability relevant data. 

 

[microbiological indicators] should indicate the name of microorganism, index and test method. 

 

【 efficacy ingredients or markers of the signature component 】 should indicate the name, index range and testing method of the functional or signature ingredients. 

 

Nutrient supplements product efficacy components shall be the products consumption of the smallest unit (e.g., each piece, each, each bag, bottle) the effect of component index, including all of the nutrients. The amount of vitamin content should be 80% to 180% of the marked value, and the mineral content should be 75% to 125%. The scope of efficacy should be in accordance with the daily intake of the appropriate population for the healthy food raw materials catalog. 

 

Efficacy ingredients or signature ingredient detection method for state standards and local standards or normative documents, include standard number or title of the normative documents; Detection methods for put on record in the national standards and local standards or revised on the basis of normative documents, include standard number or normative documents of title, document number, detail the revised content at the same time; The test method is formulated for the record person study, should list the test method full text, and provide this method to the product suitability relevant data. 

 

The filling quantity or weight difference index (net content and allow the negative deviation index)] shall be in written form to describe the load or weight difference index (net content and allow the negative deviation index). 

 

The quality standards of the original supplementary materials shall be itemized and specified. 

 

The standard number is listed in accordance with the requirements of the health food raw materials catalog and the relevant requirements of the health food record product. For pretreatment raw materials, the source and execution standard, main production procedure and key process parameters should be listed. 

 

The inspection report issued by the inspection institution with legal qualifications shall be subject to the full project inspection report 

 

5.9.1 inspection institution shall, in accordance with the provisions of technical requirements for the record in accordance with the proposed products in the project, the method of detection, issued by three batch of product technical requirements for the project inspection report. 

 

The inspection report shall include the conclusion that the test results are in conformity with the current regulations, normative documents, mandatory national standards and product technical requirements. 

 

The application form for the examination of the examination of health food and the record of the examination and acceptance of the application shall be in conformity with the product name and test indicator in the inspection report. After the examination report is issued by the inspection institution, it shall not be changed. 

 

For inspection institution with legal qualifications of unauthorized sensory requirements, efficacy ingredients or iconic component index, inspection agencies should with captions the test basis. 

 

The inspection report of 5.9.2 and the inspection report of 5.5 items shall be issued by the same surveyor, and shall be the inspection report of three different batches of products. 

 

Article 5.9.3 if the original registrant adjusts the product formulation or product technical requirements for the record, the relevant information shall be provided at 5.9.1. If the product formulation and product technical requirements are not adjusted, the inspection report submitted in the original declaration may be provided. 

 

Product name related retrieval material 

 

Record people should begin from the state administration of food and drug supervision and administration of the government website database retrieval and print, provide the name of the product (including brand name, common name and attribute name) of health food and has been approved for registration or registration name not the nuptial retrieval material. 

 

Other materials that indicate product safety and health functions 

 

Import health food record materials project and requirements 

 

In addition to submitting relevant materials according to the domestic products, it shall also be submitted: 

 

The registration certificate of the main body shall be registered 

 

Product producer (region) issued by the competent government department or the legal service agencies for the record for public health food overseas manufacturers qualification certification documents. The name of the document, the name of the manufacturer, the name of the product and the date of the document issued shall be issued. 

 

Sales of 6.2 documents shall be sold for more than a year 

 

Product producer (region) issued by the competent government department or the legal services health food similar products listed documents, sales of more than one year or sell products overseas and the safety of the crowd consumption report. 

 

Listed documents, sales of more than one year should be in the producing country (region) as a health food products like documents, product sales of more than one year shall contain the name of the file issued by institutions, for the record name address, name of production enterprises, product name and the date of the document issued by producer should clearly indicate the product conforms to the product (region) law and relevant technical regulations, standards, allowed in the country (region) production sales. Also provide the product function, eat the crowd and so on to the application record product to claim the corresponding, the assurance food safety the relevant material. 

 

If the exporter (region) approves the approval, it shall also issue a certificate of approval for the sale of the listed country by the competent department of the exporting country (region). 

 

The technical regulations or standards of the relevant technical regulations or standards of the product producing country (region) or international organization and the filing of health food. Overseas manufacturers guarantee to our export of health food products in accordance with China's relevant laws and administrative regulations and the requirements of national food safety standards, as well as ensuring the efficient operation of production quality management system of inspection report. 

 

Submitted application materials relating to the product production enterprise quality management system documents, shall be submitted to product producer (area) government competent department or the designated by the competent government department for the bear legal responsibility of issued by the relevant departments, in line with the good production quality management standard certificate, issued by the file name, product shall include name, production enterprise name and the date of the document issued by. 

 

The record-keeping person shall make sure that the source of the samples is clear and traceable, and the import record shall be the product of the listed products of the producing country (region). 

 

The packaging of the product in the product producing country (region), the label specification 

 

Should be provided with the product producer (area) go on sale the product consistent label instruction samples and photos of the notarization institution within the territory and the notarization, consistent with the original content of Chinese version. 

 

Article 6.6 the registration certificate of a resident representative of a foreign enterprise shall be submitted to the registration certificate of a resident representative of a foreign enterprise 

 

People outside the record of entrust domestic agencies to deal with the matters for the record, the original shall submit a notarized power of attorney and the entrusted agency business license scanning. The power of attorney shall specify the record, the name of the entrusted unit, the name of the product, the date of the trust and the date of the power of attorney. 

 

The documents should be used in Chinese and foreign materials. The Chinese version of the document of foreign documents and the foreign language labels shall be notarized by the notarial institutions in China and the contents of the original documents shall be consistent with the original documents. 

 

6.8 a certificate for evidence issued by the foreign institutions, such as power of attorney (agreement) shall be the original, should use the product producer (region) of the official text, filing seal or legal representative (or its authorized person) to sign, need to the notary public of the applicant's country (region) of the Chinese embassies and consulates in CRC and confirm. The document, the power of attorney (agreement), etc. Shall be used within the period of validity. 

 

6.9 to provide documents, production and sales of quality management system or good manufacturing practices, entrust processing agreement of certificate can be listed multiple products at the same time. When these products are put on record, they allow a product to use the original, other products to use a copy, and a written description of the original name of the record. These products are not put on record at the same time, a product with the original, after other products need to use a notarized copy of original written instructions and for the record the product name. 

 

7 record change 

 

To make a change for health food has been put on record, registration certificate and accessories, the content of the record shall, following the procedures in application for archival filing to the original archival filing organs according to the applications submitted to relevant data and documents. If the documents are in conformity with the requirements, they may be amended. The food and drug supervision and administration department shall place the change information in the change information and record the filing of the filing. 

 

The record of contact, contact information, such as change, should be submitted in a timely manner to the accepting institution seal of archival filing people change request, an accepting institution to update relevant information in a timely manner. 

 

Has been put on record of health food, because the product name (brand name) is not in conformity with the requirements, by regulatory authorities shall order rectification, can according to the record the change procedure. 

 

8 bylaw 

 

This guide will be revised in time for the trial version of the catalogue of the raw materials of the healthy food and the procedures for the filing.